Applying Precaution in EU Authorisation of Genetically Modified Products - Challenges and Suggestions for Reform

European Law Journal

Volumn 16, Issue 5, 2010, Pages 624-657

  Weimer, Maria ^a  

^a EUROPEAN UNIVERSITY INSTITUTE   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 77956023320     PISSN: 13515993     EISSN: 14680386     Source Type: Journal    
DOI: 10.1111/j.1468-0386.2010.00526.x     Document Type: Article

References (209)

1. E. Fisher, J. Jones and R. von Schomberg, 'Implementing the Precautionary Principle: Perspectives and Prospects', in E. Fisher, J. Jones and R. von Schomberg (eds), Implementing the Precautionary Principle (Edward Elgar1, at 11, 2006) .
2. See R. Harding and E. Fisher (eds), Perspectives on the Precautionary Principle (Federation Press, 1999)
3. T. O'Riordan, J. Cameron and A. Jordan (eds), Re-Interpreting the Precautionary Principle (Cameron May, 2001)
4. J. Morris (ed), Rethinking Risk and the Precautionary Principle (Butterworth-Heinemann, 2001)
5. I. Forrester and J. C. Hanekamp, 'Precaution, Science and Jurisprudence: a Test Case', (2006) 9(4) Journal of Risk Research 297
6. A. Wildavsky, But is it True? A Citizen's Guide to Environmental Health and Safety Issues (Harvard University Press, 3rd edn, 1997)
7. E. Fisher, 'Opening Pandora's Box: Contextualising the Precautionary Principle in the European Union', in E. Vos and M. Everson (eds), Uncertain Risks Regulated (Routledge-Cavendish, 2008)
8. C. R. Sunstein, Risk and Reason (Cambridge University Press, 2002)
9. C. R. Sunstein, Laws of Fear: Beyond the Precautionary Principle (Cambridge University Press, 2005)
10. G. Majone, 'What Price Safety? The Precautionary Principle and its Policy Implications', (2002) 40 Journal of Common Market Studies 89
11. I. S. Forrester, 'The Dangers of too Much Precaution', in M. Hoskins, D. Edward and W. Robinson (eds), A True European (Hart Publishing, 2003)
12. N. de Sadeleer, Environmental Principles: From Political Slogans to Legal Rules (Oxford University Press, 2002)
13. T. Christoforou, 'The Origins and Content of the Precautionary Principle in European Community Law', in C. Leben and J. Verhoeven (eds), Le Principe de Precaution: Aspects de Droit International et Communautaire (Pantheon Assas, LGDJ Diffuseur, 2002).
14. See all criticism raised by Sunstein, Risk and Reason and Laws of Fear, ibid.
15. See examples in Fisher et al, op cit n 1 supra, and in Harding and Fisher, op cit n 2 supra.
16. Other scholars have already paved the way for this type of research on the precautionary principle. See Fisher et al, op cit n 1 supra.
17. See U. Beck, Risk Society: Towards a New Modernity (Sage, 1992).
18. See analysis below at IV.
19. Between 2001 and 2003.
20. The European Commission announced that it would present a new proposal by the middle of July 2010, which aims at changing the current EU framework for GMO cultivation and allowing for more Member State autonomy to prohibit cultivation on national territories. See Commission Press Release, 2 March 2010, available at, This paper could not consider the announced change as it went into print before the announcement of the Commission proposal. http://europa.eu/rapid/pressReleasesAction.do?reference=IP/10/222
21. See French Presidency Proposal, available at http://66.102.9.132/search?q=cache:mOddKHsaDR4J:register.consilium.europa.eu/pdf/en/08/st07/st07128.en08.pdf+7128/08+GMOs:+Exploring+the+way+forward&hl=en&ct=clnk&cd=1&gl=be&client=firefox-a
22. Another parallel reflection group was set up by Commission President Jose Barrosso; see press article on EurActiv, available at http://www.euractiv.com/en/environment/france-propose-concrete-solutions-eu-gmo-muddle/article-174002.
23. See the 'Environment' Council Conclusions on Genetically Modified Organisms from 5 December 2008, available at http://register.consilium.europa.eu/pdf/en/08/st16/st16882.en08.pdf.
24. For lists of national measures see the Directorate General Environment website, available at http://ec.europa.eu/environment/biotechnology/safeguard_measures.htm.
25. See Euractiv, EU to Overhaul GM Crop Approval System, 4 June 2010, available at http://www.euractiv.com/en/cap/eu-overhaul-gm-crop-approval-system-news-494896
26. J. M. Barroso, Political Guidelines for the Next Commission, 3 September 2009, p 39, available at http://ec.europa.eu/commission_2010-2014/president/about/political/index_en.htm.
27. See Sunstein, Laws of Fear, op cit n 2 supra.
28. See Christoforou, op cit n 2 supra; on the existence of different approaches to precaution even under the EU legal system, see E. Fisher, Risk Regulation and Administrative Constitutionalism (Hart Publishing, 2007).
29. See for an overview Harding and Fisher, op cit n. 2 supra; O'Riordan et al, op cit n 2 supra.
30. However, the EU has already adapted a precautionary approach in a number of Directives and policy documents before the introduction of the principle in the Treaties; see examples in A. Jordan, 'The Precautionary Principle in the European Union', in: O'Riordan et al, op cit n 2 supra, 143, at 148 et seq.
31. See on the dependence of precautionary definitions upon the jurisprudential and jurisdictional context, Fisher, op cit n 2 supra; also Fisher, op cit n 15 supra.
32. See op cit n 2 supra.
33. See Fisher, op cit n 2 supra; see also, albeit in stricter terms, the Rio Declaration.
34. E. Fisher, 'Precaution, Precaution Everywhere: Developing a "Common Understanding" of the Precautionary Principle in the European Community', (2002) 9 Maastricht Journal of European and Comparative Law 7, referring to the independent expert group on mobile phones (IEGMP), Report - Mobile Phones and Health (HMSO, 2000), at 6.16.
35. See Fisher et al, op cit n 1 supra, at 11.
36. See Communication from the Commission on the Precautionary Principle, COM (2000) 1.
37. See, eg, Fisher, op cit n 15 supra; P. Craig, EU Administrative Law (Oxford University Press, 2006), ch 19; J. Scott, 'The Precautionary Principle Before the European Courts', in R. Macrory (ed), Principles of European Environmental Law (Europa Law Publishing, 2004)
38. J. Scott and E. Vos, 'The Juridification of Uncertainty: Observations on the Ambivalence of the Precautionary Principle within the EU and the WTO', in C. Joerges and R. Dehousse (eds), Good Governance in Europe's Integrated Market (Oxford University Press, 2002).
39. Following the Lisbon Treaty reform the Court of First Instance is now referred to as the General Court; see Art 254 TFEU. As this paper refers to the court's jurisdiction before the entry into force of the Lisbon Treaty, it will in the following maintain the reference to the Court of First Instance.
40. See Case T-13/99, Pfizer Animal Health SA v Council [2002] ECR II-3305; Case T-70/99, Alpharma v Council [2002] ECR II-3495; see also Fisher, op cit n 15 supra who compares EC case-law before and after the publication of the Communication.
41. Commission Communication, op cit n 23 supra, at 9.
42. ibid, at 3. The third element of risk analysis mentioned there is risk communication, which is defined as involving 'the interactive exchange of information, both within and beyond risk analysis as a whole, with an emphasis on "the explanation of risk assessment findings and the basis or risk management decisions"'; see A. Stirling, O. Renn and P. van Zwanenberg, 'A Framework for the Precautionary Governance of Food Safety: Integrating Science and Participation in the Social Appraisal of Risk', in Fisher et al, op cit n 1 supra.
43. Commission Communication, ibid, at 3 and 13.
44. Scott and Vos, op cit n 24 supra, at 278.
45. See for a detailed analysis of the case-law before and after the Communication, Fisher, op cit, n 15 supra.
46. Case C-180/96, UK v Commission [1998] ECR I-2265.
47. The reasoning of the ECJ was based on a combined reading of Art 174(1) and Art 174 (2) EC; see ibid, para 100; see for a more detailed explanation of the court's legal reasoning Craig, op cit n 24 supra, at 718.
48. UK v Commission, n 41 supra, para 99.
49. See Case C-157/96, The Queen v Ministry of Agriculture, Fisheries and Food, Commissioners of Customs & Excise, ex p National Farmers' Union [1998] ECR I-2211; with regard to actions brought against Member States, see Case C-174/82, Officier van Justitie v Sandoz BV [1983] ECR 2445; Case 247/84, Criminal proceedings against Leon Motte [1985] ECR 3887; Case 54/85, Ministère public against Xavier Mirepoix [1986] ECR 1067; Case C-473/98, Kemikalieinspektionen v Toolex Alpha AB [2000] ECR I-5681.
50. See Case T-13/99, Pfizer Animal Health SA v Council [2002] ECR II-3305; Case T-70/99, Alpharma v Council [2002] ECR II-3495; Cases T-74, 76, 83-85, 132, 137 and 141/00, Artegodan GmBH v Commission [2002] ECR II-4945, at para 184.
51. See Commission Communication, op cit n 23 supra, at 10.
52. See Scott, op cit n 24 supra, at 54; see also P. Craig and G. De Burca, EU Law (Oxford University Press, 2008) chs 8 and 9.
53. As a general legal principle of EU law the precautionary principle is also binding upon the Member States when they are acting within the scope of Community law; see Scott, ibid, at 54; Craig, op cit n 24 supra, at 731.
54. See Case C-236-1, Monsanto Agricoltura Italia SpA v Presidenza del Consiglio dei Ministri [2003] ECR I-8105, at para 133.
55. See Pfizer, n 45 supra, paras 123 and 149.
56. See Case C-192/01, Commission v Denmark [2003] ECR I-9693, Advocate General Mischo, para 89; see also Fisher, op cit n 15 supra, at 231.
57. See Pfizer, n 45 supra, para 172.
58. ibid, para 147; see criticism of the notion of risk underlying this jurisprudence Fisher, op cit n 15 supra, at 229 et seq; more generally on limitations of traditional risk assessment with regard to new technologies J. Holder and M. Lee, Environmental Protection, Law and Policy, (Cambridge University Press, 2007), at 18.
59. See Pfizer, n 45 supra, para 201.
60. ibid, para 166 and other judgments stated therein; also Scott, op cit n 24 supra.
61. See Pfizer, n 45 supra, para 168 and other judgments cited therein.
62. However, despite using the same formula of 'manifest error of appraisal' in Artegodan, n 45 supra, the Court of First Instance went on and nevertheless reviewed the consistency of the scientific assessment; see para 197 et seq of the judgment.
63. For a substantial overview of existing GMO legislation, see T. Christoforou, 'The Regulation of Genetically Modified Organisms in the European Union: The Interplay of Science, Law and Politics', (2004) 41 Common Market Law Review 637; M. Lee, EU Regulation of GMOs (Edward Elgar, 2008).
64. Council Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, [2001] OJ L106/1.
65. Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms, [1990] OJ L117/15.
66. Holder and Lee, op cit n 53 supra, at 188.
67. This dual objective is also expressed in recitals 5 and 7 of the Preamble to Dir 2001/18/EC.
68. Regulation (EC) 1829/2003 on genetically modified food and feed, [2003] OJ L268/1.
69. See recital 9 of the Preamble to Reg 1829/2003; the previous authorisation procedure for GM food was governed by Regulation 258/97 concerning novel foods and novel food ingredients.
70. It should be noted that, in practice, there is strong overlapping between the scopes of application of both laws. In fact, companies that want to place on the market a food/feed product containing GMOs or consisting of them have the choice of submitting either a single application under the Reg 1829/2003, thus obtaining a single Community authorisation including cultivation of the product; or they submit applications under both Dir 2001/18 and Reg 1829/2003. See further European Commission, Questions and Answers on the Regulation of GMOs in the European Union, available at http://ec.europa.eu/food/food/biotechnology/gmfood/qanda_en.htm.
71. 'Deliberate release' is defined in Art 2(3) of Dir 2001/18/EC as 'any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment'.
72. Dir 2001/18/EC, Part C.
73. ibid, Part B.
74. See ibid, Art 13(2)(b) and Annex II.
75. Similar observations apply to the authorisation of GMOs as feed products, dealt with in Chapter III of Reg 1829/2003. For the sake of simplification I will confine my explanations to GM food.
76. See ibid, Art 1 and recital 9 of the preamble.
77. Regulation (EC) laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, [2002] OJ L31/1.
78. See M. I. Kritikos, Institutions and Science in the Authorization of GMO Relesases in the European Union (1990-2007): The False Promise of Proceduralism, PhD Thesis (London School of Economics, 2007), at 166.
79. See above at IIIA.
80. See Reg 1829/2003, Art 1.
81. See White Paper on Food Safety, COM (1999) 719.
82. For an overview of the historical developments leading to this overhaul, ie the BSE and other food scandals of the 1990s, see C. Shaffer and M. Pollack, 'Agricultural Biotechnology Policy in the EU: Between National Fears and Global Disciplines', in H. Wallace, W. Wallace and M. Pollack (eds), Policy-Making in the European Union (Oxford University Press, 5th edn, 2005).
83. See Reg 178/2002, Art 1.
84. See recital 20.
85. See ibid, Art 7.
86. See ibid, Art 22.
87. Although the system under the Directive, in principle, establishes a national authorisation procedure, in practice, so far, every authorisation was dealt with under the Community procedure.
88. See Dir 2001/18, Arts 18(1) and 30(2), as well as Reg 1829/2003, Arts 7(3) and 35(2).
89. Note that the analysis in this paper refers to the authorisation practice under the 'old' comitology system, ie Council Decision 1999/468/EC [1999] OJ L184/23, as amended by Council Decision 2006/512/EC [2006] OJ L200/11. This system is likely to be repealed due to the entry into force of the Treaty of Lisbon. Following the new Art 291(3) of the TFEU, the Council and the European Parliament are required to enact new legislation replacing the current comitology system. A major change to be introduced is that the participation of the Council in the control of Commission implementing acts will be abolished. See Commission Proposal for a Regulation of the European Parliament and of the Council laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers, COM (2010) 83 final from 9 March 2010.
90. Defined in Reg 178/2002, Art 7; see below at IV.B.
91. See Z. K. Forsman, 'Community Regulation of Genetically Modified Organisms: A Difficult Relationship Between Law and Science', (2004) 10(5) European Law Journal 580, at 581; Shaffer and Pollack, op cit n 83 supra, at 342.
92. See also R. von Schomberg, 'The Precautionary Principle and its Normative Challenges', in Fisher et al, op cit n 1 supra, at 26, who with regard to the GMO framework speaks about a 'particular design of a precautionary regulatory framework'.
93. On these two meanings of the precautionary principle, see Fisher, op cit n 21 supra; Stirling et al, op cit n 29 supra.
94. See Dir 2001/18, Art 13(1) and Reg 1829/2003, Art 4(2).
95. See Dir 2001/18, recitals 4 and 5.
96. Case C-66/99, Association Greenpeace France v Ministère de l'Agriculture et de la Pêche [2000] ECR I-1651.
97. See Commission Communication, op cit n 23 supra, at 21; see also in the context of Australian administrative law, J. Jones and S. Bronitt, 'The Burden and Standard of Proof in Environmental Regulation: The Precautionary Principle in an Australian Administrative Context', in Fisher et al, op cit n 1 supra.
98. See Reg 1829/2003, Art 4(3); the Directive does not contain a similar explicit provision on the burden of proof, but the shift of burden follows from a combined reading of Dir 2001/18, Arts 4(2) and 13.
99. By virtue of Reg 1829/2003, Art 1, the principle of risk analysis directly applies to the GM Food Regulation; although, as such, the principle is not mentioned in the Directive, the structured approach to risk analysis as formulated in the Commission Communication governs the administrative practice of the Commission also under the Community procedure of Directive 2001/18, since the Commission Communication constitutes a self-binding commitment of the Commission to exercise its discretion in a certain way; see Pfizer, n 45 supra, paras 119 and 123.
100. These requirements are formulated in Reg 1829/2003, Art 4(1) for GM food; for GMOs to be placed on the market under the Directive, Dir 2001/18, Art 4(1) applies.
101. See also the definitions in Reg 178/2002, Art 3(11) and (12).
102. See, eg, D. Chalmers, 'Risk, Anxiety and the European Mediation of the Poltics of Life', (2005) 30(5) European Law Review 649
103. E. Vos and F. Wendler, 'Food Safety Regulation at the EU Level', in E. Vos and F. Wendler (eds), Food Safety Regulation in Europe. A comparative institutional analysis (Intersentia, 2006).
104. See D. Chalmers, '"Food For Thought:" Reconciling European Risk and Traditional Ways of Life', (2003) 66 Modern Law Review 532, at 538.
105. E. Chiti, 'Decentralisation and Integration into the Community Administrations: A New Perspective on European Agencies', European Law Journal, (2004) 10(4) 402
106. T. Groß, 'Kooperation zwischen Europäischen Agenturen und nationalen Behörden', (2005) Europarecht 54.
107. On the integrative institutional structures of EFSA, see M. Weimer, 'Legitimacy through Precaution in European Regulation of GMOs? From the Standpoint of Governance as Analytical Perspective', in C. Joerges and P. Kjaer (eds), Transnational Standards of Social Protection (ARENA, 2008), available at http://www.reconproject.eu/main.php/RECONreport0408.pdf?fileitem=3522579.
108. The term network is understood as an analytical category in the sense of 'an entity in which different parts are loosely linked, but not fixed together. The single elements are autonomous from, yet not necessarily equal to each other'. See H. Türk and H. Hofmann, 'An Introduction to EU Administrative Governance', in H. Hofmann and H. Türk (eds), EU Administrative Governance (Edward Elgar, 2006)
109. see also G. Sydow, Verwaltungskooperation in der Europäischen Union (Mohr Siebeck, 2004), at 79.
110. In case of a GM food product, it is the Standing Committee on Animal Health and Food Chain, see Reg 1829/2003, Art 35; in case of an application under Dir 2001/18, see Art 30.
111. See n 90 supra.
112. C. Joerges and J. Neyer, 'Transforming Strategic Interaction Into Deliberative Problem-Solving: European Comitology in the Foodstuffs Sector', (1997) 4(4) Journal of European Public Policy 609, at 620. On comitology as governance, see P. Kjaer, Between Governing and Governance: On the Emergence, Function and Form of Europe's Post-national Constellation, PhD Thesis (European University Institute, 2008).
113. See Art 5 of Council Decision 1999/468, [1999] OJ L184/23. For an explanation of the regulatory procedure, see Vos and Wendler, op cit n 103 supra, at 89. Note that following the Commission proposal on a new 'Comitology' Regulation, the regulatory procedure is likely to be replaced by a new 'examination' procedure; see n 90 supra.
114. In the case of the GM Food Regulation, it is the Standing Committee on the Food Chain and Animal Health (SCFCAH); see n 108 supra.
115. See Sydow, op cit n 107 supra, at 221.
116. See below at V.
117. See Commission Communication, op cit n 23 supra.
118. See analysis above at II.B.
119. See also T. Christoforou, 'The Precautionary Principle and Democratizing Expertise: A European Legal Perspective', (2003) 30(3) Science and Public Policy 205.
120. See Pfizer, op cit n 54 supra.
121. See on precautionary governance structures, Stirling et al, op cit n 29 supra.
122. Under the Directive, the Member States have this duty, but only as long as the standard and not the Community procedure for marketing authorisation applies; see above at III.A.
123. See above at III.A.
124. See above at II.B.
125. See analysis above at II.A.
126. See Commission Communication, op cit n 23 supra.
127. See analysis above at II.B.
128. The European courts so far have only dealt with Reg 178/2002, Art 7 en passant, confirming the view that it codifies the previous Community case-law on the precautionary principle for the area of EU food law. See Case C-453/03, ABNA Ltd and others v Secretary of State for Health and Food Standards Agence [2005] ECR I-10423, Advocate General Tizzano; Case C-41/02, Commission v Kingdom of the Netherlands [2004] ECR I-11375, Advocate General Maduro.
129. See on the nature of the Commission Communication as a self-imposed limitation of the Commission's discretion, Pfizer, n 45 supra, paras 119 and 123.
130. See Reg 1829/2003, Art 7(1).
131. See Reg 178/2002, Art 6(3), which states that the precautionary principle shall be taken into account in a risk management decision only 'where the conditions laid down in Article 7(1) are relevant'.
132. See Pfizer, n 45 supra, paras 142-144; see also Case C-244, France v Parliament [2005] ECR I-4021, Advocate General Geelhoed, para 107; see also Case E-3/00, EFTA Surveillance Authority v Norway [2001] 2 CMLR 47, where the EFTA court has interpreted the required level of potential risk in restrictive, probabilistic terms; see paras 30-32.
133. See on the requirements on this justification developed in the case-law, Pfizer, n 45 supra, para 199.
134. This is demonstrated by provisions such as, eg, Reg 178/2002, Arts 30 and 36.
135. In Pfizer and Artegodan, n 45 supra, the Court of First Instance has admitted that the Community institutions can make recourse to other sources of scientific research; see, eg, Pfizer, paras 199 and 204.
136. See above at II.
137. In the currently ongoing reflection process on GMO legislation, this issue seems to be the bone of contention between the Member States and the Commission, although, unfortunately, it is discussed without any reference to the precautionary principle; see references at n 10 supra. It remains to be seen whether this process will accomplish clarifying the way in which the legislative provisions should be implemented.
138. Pfizer, n 45 supra, paras 199 and 204; see also A. Alemanno, 'EU Risk Regulation and Science: The Role of Experts in Decision-Making and Judicial Review', in E. Vos (ed), European Risk Governance (Connex, 2008) 37, at 49.
139. See n 56 supra.
140. Submitted under either Dir 2001/18 or Reg 1829/2003.
141. See Community register on authorisation, available at http://ec.europa.eu/food/dyna/gm_register/index_en.cfm.
142. See Council Decision 1999/468, Art 5(6). Note future changes in the comitology system as explained above; see n 90 supra.
143. See Vos and Wendler, op cit n 103 supra 116; Chalmers, op cit n 103 supra, at 656.
144. See Vos and Wendler, ibid, at 89.
145. So far, the Council reached a qualified majority against the Commission only in procedures concerning the lifting of national cultivation bans on GMOs; in June 2005, it opposed the Commission proposal to lift eight bans invoked by five Member States; and in March 2009 the Council rejected the Commission's recommendation to lift cultivation bans upheld in Austria and Hungary. See the website available at http://www.gmo-compass.org/eng/news/422.cultivation_ban_gm_maize_austria_hungary_remains.html
146. see also Holder and Lee, op cit n 53 supra, at 197.
147. Vos and Wendler, op cit n 103 supra, at 129.
148. Holder and Lee, op cit n 53 supra, at 195.
149. According to the Eurobarometer, Europeans and Biotechnology in 2005: Patterns and Trends, published in May 2006, only an average of 27% of the European population encourages the technology of GM food.
150. See list of national measures on the Directorate General Environment website, available at http://ec.europa.eu/environment/biotechnology/safeguard_measures.htm
151. A recent example is the invocation by Germany of a safeguard measure under Dir 2001/18 against the MON 810 Bt maize; see GMO Compass, Germany: Minister Aigner bans MON810 Bt maize, available at http://www.gmo-compass.org/eng/news/432.docu.html.
152. See La Repubblica, op cit n 13 supra. See also Chalmers, op cit n 103 supra, at 663 who emphasises the ambiguous role Member States play in the comitology voting.
153. See, eg, Commission Decision 2008/280/EC of 28 March 2008 [2008] OJ L87/19, authorising placing on the market products from maize GA21, Preamble (4); for other GM food and feed authorisations, see Community register, available at http://ec.europa.eu/food/dyna/gm_register/index_en.cfm.
154. See, eg, press article by The Independent from October 2008, available at http://www.independent.co.uk/environment/green-living/europes-secret-plan-to-boost-gm-crop-production-973834.html.
155. See references at n 13 supra.
156. Article 251 EC (Art 293 TFEU).
157. See references at nn 10 and 11 supra.
158. See for lists of all pending cases for authorisation, the website available at http://ec.europa.eu/environment/biotechnology/authorised_prod.htm.
159. See Case T-139/07, Pioneer Hi-Bred International v Commission, application published in [2007] OJ C155/28; and Case T-293/08, BASF Plant Science and Others v Commission, application published in [2008] OJ C272/28.
160. Even under the so-called de facto moratorium there was no direct legal action against the Commission. The European courts, so far, only had to assess national safeguard measures issued under the GMO legislation or under Art 95(5) EC. See Monsanto, n 49 supra; also Joined Cases T-366/03 and T-235/04, Land Oberösterreich and Republic of Austria v Commission [2005] ECR II-4005 and Joined Cases C-439/05P and C-454/04P, Land Oberösterreich and Republic of Austria v Commission [2007] ECR I-7141.
161. See the status of application, available at http://www.gmo-compass.org/eng/gmo/db/75.docu.html. See also Pioneer press statement, available at http://www.pioneer.com/web/site/portal/menuitem.646ebc4966a3a245abfe06e2d10093a0/.
162. Several Member States have invoked safeguard clauses under the Dir 90/220/EEC and Dir 2001/18 in order to ban other maize products containing the Bt-toxin, notably maize Bt-176 and MON810. See the Commission list, op cit n 147 supra.
163. See on this procedure above at III.A.
164. See EFSA opinion from 15 January 2005 with annexes in (2005) 181 The EFSA Journal 1.
165. See ibid, the annexes of the EFSA opinion, as well as its opinion from 29 October 2008 in (2008) 851 The EFSA Journal 1.
166. See the text of the draft decision as well as the status of the procedure in the Commission's comitology register, available at http://ec.europa.eu/transparency/regcomitology/searchform/DocumentDetail.cfm?9wwT5pyZcRzT7ifmAwES+Joo/uoFIgVCvxTR6loUMV/j83kKhIhMeIoQkhazA52W.
167. See on the status of the applications, available at http://www.gmo-compass.org/eng/gmo/db/16.docu.html and at http://www.gmo-compass.org/eng/gmo/db/17.docu.html; see also BASF press statement, available at http://www.corporate.basf.com/de/produkte/biotech/?getasset=file3&name=PI351_BASF_Fall_Amflora_vor_EU-Gericht.pdf&MTITEL=BASF+Plant+Science+bringt+den+Fall+Amflora+vor+EU-Gericht&suffix=pdf&id=0MHVcDAGzbcp-OZ.
168. See EFSA Opinion from 2 April 2004 in (2004) 48 The EFSA Journal 1.
169. See EFSA opinion from 7 December 2005 on the placing on the market for food/feed uses in (2006) 324 The EFSA Journal 1; and EFSA opinion from 7 December 2005 on the placing on the market for cultivation in (2006) 323 The EFSA Journal 1.
170. See GMO Compass, Commission to Approve Five GMOs, available at http://www.gmo-compass.org/eng/news/336.commission_approve_five_gmos.html.
171. See GMO Compass, Zulassung Amflora-Kartoffel: BASF zieht vor Gericht, available at http://www.transgen.de/aktuell/957.doku.html.
172. See Commission Decision 2010/135/EU of 2 March 2010, [2010] OJ L53/11, authorising the placing on the market for cultivation and Commission Decision 2010/136/EU of 2 March 2010, [2010] OJ L53/15, authorising the placing on the market for food and feed use.
173. Both cases have become devoid of purpose in the course of the proceedings due to Commission decisions adopted after the applications have been filed. See order to close Case T-139/07, Pioneer Hi-Bred International v Commission [2009] OJ C267/64; Case T-293/08, BASF Plant Science and Others v Commission [2008] OJ C272/28 is still pending.
174. See statements of the EU Commissioner for Environment, Stavros Dimas reported on GMO Compass, available at http://www.gmo-compass.org/eng/news/messages/200710.docu.html#167 and on Transgen, available at http://www.transgen.de/aktuell/957.doku.html; see also press article on EurActiv, available at http://www.euractiv.com/en/environment/commission-hesitant-approve-gm-crops/article-172209.
175. See Sunstein, Risk and Reason and Laws of Fear, op cit n 2 supra.
176. See above at III.A.
177. See Arts 2.2 and 5.7 of the Agreement on the Application of Sanitary and Phytosanitary Measures; Appellate Body Report, WT/DS18/AB/R, Australia - Salmon, 6 November 1998, para 125; also Forsman, op cit n 92 supra, at 591 and 592 with further references to Codex Alimentarius rules.
178. See J. Scott, European Regulation of GMOs: Thinking about 'Judicial Review' in the WTO, Jean Monnet Working Paper, 2004/04; see also C. Joerges, 'Sound Science in the European and Global Market: Karl Polanyi in Geneva', in Vos and Everson, op cit n 2 supra.
179. Forsman, op cit n 92 supra, at 591.
180. See A. Stirling, On Science and Precaution in the Management of Technological Risk, An ESTO Project Report (JRC, Institute for Prospective Technological Studies, Sevilla, 1999); B. Wynne, 'Uncertainty and Environmental Learning', (1992) 2(2) Global Environmental Change 113; J. Steele, Risks and Legal Theory (Hart Publishing, 2004).
181. See above at IV.B.
182. The Environmental Council in its declaration on GMOs from December 2008 stipulates an obligation for the Commission to submit two reports with regard to the socio-economic implications of the placing on the market of GMOs, one of them by January 2010. See Council Conclusions, op cit n 11 supra, at 5.
183. First steps to develop such methodology are based on cost-benefit analysis techniques, which are mentioned as part of the application of the precautionary principle in the Commission Communication, op cit n 23 supra, at 19; critical on cost-benefit techniques in the US context, see D. A. Kysar, 'It Might Have Been: Risk, Precaution and Opportunity Costs', (2006) 22(1) Journal of Land Use and Environmental Law 1; an example for a regulatory system, which includes the appraisal of socio-economic risks, is the REACH framework. Article 85 of Reg 1907/2006 establishing the European Chemicals Agency foresees not only a Committee for Risk Assessment, but also a Committee for Socio-Economic Risk Analysis. On the REACH framework, see P. Kjaer, Rationality within REACH? On Functional Differentiation as the Structural Foundation of Legitimacy in European Chemicals Regulation, EUI Working Papers Law 2007/18.
184. On the misuse of science as justification for political decisions in the regulation of new technological risks, see Fisher, op cit n 21 supra, at 9; Holder and Lee, op cit n 53 supra, at 18.
185. The Commission itself acknowledges the need to exercise political self-restraint in such cases; see statement concerning Art 5 of Council Decision 1999/468, [1999] OJ C203/1.
186. See above at II.
187. See D. Garland, 'The Rise of Risk', in R. V. Ericson and A. Doyle (eds), Risk and Morality (University of Toronto Press, 2003); P. L. Bernstein, Against the Gods: The Remarkable Story of Risk (John Wiley and Sons, 1996); A. Giddens, 'Risk and Responsibility', (1999) 62 Modern Law Review 1; Beck, op cit n 6 supra; Steele, op cit n 177 supra.
188. Fisher, op cit 21 supra, at 16 with reference to R. Dworkin, Taking Rights Seriously (Duckworth, 1977), at 26; see also A. Herwig, 'The Precautionary Principle in Support of Practical Reason: An Argument Against Formalistic Interpretations of the Precautionary Principle', in C. Joerges and E.-U. Petersmann (eds), Constitutionalism, Multilevel Trade Governance and Social Regulation (Hart Publishing, 2006) 301, at 303.
189. Holder and Lee, op cit n 53 supra, at 21, 22 and 29.
190. Fisher, op cit n 2 supra.
191. See in a similar vein M. Everson and E. Vos, 'European Risk Governance in a Global Context', in E. Vos (ed), European Risk Governance (Connex, 2008) 7, at 31.
192. I use this term here in the 'Habermasian' sense of a discursive process based upon persuasion and the exchange of arguments, which provides an opportunity for open debate in which all the contending positions and interests in GMO regulation are included. See J. Habermas, Between Facts and Norms (MIT Press, 1996); J. Black, 'Proceduralizing Regulation: Part I', (2000) 20 Oxford Journal of Legal Studies 597.
193. See Everson and Vos, op cit n 188 supra; M. Everson, 'Three Intimate Tales of Law and Science: Hope, Despair and Transcendence', in E. Vos (ed), Uncertain Risks Regulated (Routledge-Cavendish, 2009), 347.
194. See Lee, op cit n 58 supra, chs 4 and 5.
195. See on the term 'public space' (Öffentlichkeit), Habermas, op cit n 190 supra, at 435.
196. See Everson, op cit n 191 supra, at 356.
197. For a more detailed account of these structures, see Weimer, op cit n 106 supra, at 187.
198. On precautionary governance in food regulation, see Stirling et al, op cit n 29 supra.
199. See Commission Communication, op cit n 23 supra.
200. See B. Wynne, (2001) 10(4) 'Creating Public Alienation: Expert Cultures of Risk and Ethics on GMOs', Science as Culture 445; on the application of the precautionary principle already in the risk assessment
201. P. von Zwanenberg and A. Stirling, 'Risk and Precaution in the US and Europe: A Response to Vogel', in H. Somsen et al (eds), Yearbook of European Environmental Law, Vol 3 (Oxford University Press, 2004), at 47.
202. See for more detail as well as the distinction of different forms of public participation, M. Dreyer and O. Renn, 'Some Suggestions for a Structured Approach to Participation in Food Risk Governance with a Special Emphasis on the Assessment Management Interface', in E. Vos (ed), European Risk Governance (Connex, 2008), at 89.
203. See Reg 1829/2003, Art 6(7).
204. On the false promise of public participation channels in the GMO authorisation, see M. P. Ferretti, 'Why Public Participation in Risk Regulation? The Case of Authorizing GMO Products in the European Union', (2007) 16 Science as Culture 377.
205. See Commission Communication, op cit n 23 supra, at 16.
206. See Everson and Vos, op cit n 188 supra, at 31.
207. See for criticism of such approach, Fisher, op cit n 21 supra; Fisher, op cit n 15 supra.
208. Pfizer, n 45 supra, para 172.
209. See on social appraisal of risk, Stirling et al, op cit n 29 supra.